ID
30364
Description
Study ID: 108414 Clinical Study ID: DBU108414 Study Title: TXA107979: A placebo-controlled, single blind, randomized two part study to investigate the tolerability, pharmacokinetics, and brainDopamine D3 receptor occupancy of increasing repeat doses ofGSK618334 for up to 21 days in healthy volunteers. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01036061 https://clinicaltrials.gov/ct2/show/NCT01036061 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK618334 Study Indication: Substance Dependence Documentation part: Visit Documentation 21 Specification: PET LDD
Link
https://clinicaltrials.gov/ct2/show/NCT01036061
Keywords
Versions (1)
- 5/30/18 5/30/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
May 30, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Tolerability, pharmacokinetics, and brain Dopamine D3 receptor occupancy of increasing repeat doses of GSK618334 in healthy adults NCT01036061
Visit Documentation 21
- StudyEvent: ODM
Description
Investigational Product
Alias
- UMLS CUI-1
- C0304229
Description
Vital Signs
Alias
- UMLS CUI-1
- C0518766
Description
Time from last dose of investigational product until Vital Signs measurement
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
- UMLS CUI [1,3]
- C0518766
Description
Semi Supine
Data type
integer
Alias
- UMLS CUI [1,1]
- C1262869
- UMLS CUI [1,2]
- C0518766
Description
Actual date of vital signs
Data type
date
Alias
- UMLS CUI [1]
- C2826644
Description
Actual time of vital signs
Data type
time
Alias
- UMLS CUI [1]
- C2826762
Description
Systolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Description
Diastolic Blood Pressure
Data type
integer
Measurement units
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Description
Heart rate
Data type
integer
Measurement units
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Description
Respiration rate
Data type
integer
Measurement units
- breaths/min
Alias
- UMLS CUI [1]
- C0231832
Description
Temperature
Data type
float
Measurement units
- C
Alias
- UMLS CUI [1]
- C0005903
Description
ECG
Alias
- UMLS CUI-1
- C1623258
Description
Following please answer specific ECG forms (f.e.: Holter ECG Abnormalities) PET LDD: 12-lead-ECG, Telemetry (0-6hrs)
Data type
integer
Alias
- UMLS CUI [1]
- C1623258
Description
Time from last dose of investigational product until ECG
Data type
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C2348792
Description
Start Date ECG
Data type
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0808070
Description
Start Time ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1301880
Description
Stop Date ECG
Data type
date
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0806020
Description
Stop Time ECG
Data type
time
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C1522314
Description
Duration of ECG recording
Data type
integer
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0449238
Description
Meal
Alias
- UMLS CUI-1
- C3842710
- UMLS CUI-2
- C0012155
Description
Start date Meal
Data type
date
Alias
- UMLS CUI [1,1]
- C3842710
- UMLS CUI [1,2]
- C0808070
Description
Start time meal
Data type
time
Alias
- UMLS CUI [1,1]
- C3842710
- UMLS CUI [1,2]
- C1301880
Description
Type of Meal
Data type
text
Alias
- UMLS CUI [1,1]
- C3842710
- UMLS CUI [1,2]
- C0332307
Description
Percentage of Meal Consumed
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C3842710
- UMLS CUI [1,2]
- C0205197
Description
Pharmacokinetics Blood
Alias
- UMLS CUI-1
- C0031327
- UMLS CUI-2
- C0005767
Description
Time from last dose of investigational product until Clinical Chemistry measurement
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
Description
Actual Time of Pharmacokinetics Blood
Data type
time
Alias
- UMLS CUI [1,1]
- C0031328
- UMLS CUI [1,2]
- C0040223
Description
Pharmacokinetics Urine
Alias
- UMLS CUI-1
- C0031328
- UMLS CUI-2
- C0042036
- UMLS CUI-3
- C0022885
Description
sample collected
Data type
boolean
Alias
- UMLS CUI [1]
- C0200354
Description
Pharmacokinetics Urine Start Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0808070
Description
Pharmacokinetics Urine Start Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1301880
Description
Pharmacokinetics Urine Stop Date
Data type
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0806020
Description
Pharmacokinetics Urine Stop Time
Data type
time
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C1522314
Description
Total sample volume
Data type
float
Measurement units
- ml
Alias
- UMLS CUI [1]
- C1278293
Description
Total sample weight
Data type
float
Measurement units
- g
Alias
- UMLS CUI [1,1]
- C0807984
- UMLS CUI [1,2]
- C0200354
Description
Sample pH
Data type
float
Alias
- UMLS CUI [1]
- C0042044
Description
Haematology
Alias
- UMLS CUI-1
- C0474523
- UMLS CUI-2
- C0022885
Description
Haematology sampling date and time
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C0040223
Description
Time from last dose of investigational product until Haematology
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
- UMLS CUI [1,3]
- C0474523
Description
Fasting
Data type
boolean
Alias
- UMLS CUI [1]
- C0015663
Description
Please answer the following questions for each Haematology Analyte
Data type
integer
Alias
- UMLS CUI [1]
- C0018941
Description
Type of result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Description
Haematology Numeric Result
Data type
float
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2347373
Description
Haematology Character Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0474523
- UMLS CUI [1,2]
- C2350015
Description
Clinical Chemistry
Alias
- UMLS CUI-1
- C0008000
Description
Date and time sample taken
Data type
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Description
Time from last dose of investigational product until Clinical Chemistry
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
- UMLS CUI [1,3]
- C0008000
Description
Fasting
Data type
boolean
Alias
- UMLS CUI [1]
- C0015663
Description
Please answer the following questions for each Clinical Chemistry Analyte
Data type
integer
Alias
- UMLS CUI [1]
- C0008000
Description
Type of result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Description
Clinical Chemistry Numeric Result
Data type
float
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2347373
Description
Clinical Chemistry Character Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0008000
- UMLS CUI [1,2]
- C2350015
Description
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
Description
Time from last dose of investigational product until Urinalysis
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
- UMLS CUI [1,3]
- C0042014
Description
Date sample taken
Data type
date
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C1302413
Description
Time sample taken
Data type
time
Alias
- UMLS CUI [1,1]
- C0200354
- UMLS CUI [1,2]
- C4064021
Description
Result of dipstick
Data type
integer
Alias
- UMLS CUI [1,1]
- C1160927
- UMLS CUI [1,2]
- C0587081
Description
If Yes, provide details of repeated tests in the add entry section below
Data type
boolean
Alias
- UMLS CUI [1,1]
- C2700128
- UMLS CUI [1,2]
- C0587081
Description
Urinalysis - Local: Dipstick Details
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
- UMLS CUI-3
- C0022885
Description
Time from last dose of investigational product until Urinalysis
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
- UMLS CUI [1,3]
- C0042014
Description
Please answer the following questions for each Urinalysis Analyte
Data type
integer
Alias
- UMLS CUI [1]
- C0042014
Description
Type of result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Description
Urinalysis Numeric Result
Data type
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2347373
Description
Urinalysis Character Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2350015
Description
Urinalysis - Local: Microscopy Details
Alias
- UMLS CUI-1
- C0430397
- UMLS CUI-2
- C0042014
Description
Time from last dose of investigational product until Urinalysis
Data type
integer
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0946444
- UMLS CUI [1,3]
- C0042014
Description
Please answer the following questions for each Urinalysis Analyte
Data type
integer
Alias
- UMLS CUI [1]
- C0430397
Description
Type of result
Data type
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C0332307
Description
Urinalysis Numeric Result
Data type
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2347373
Description
Urinalysis Character Result
Data type
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C2350015
Description
Questionnaires
Alias
- UMLS CUI-1
- C0034394
Description
Please fill out 3h after dosing
Data type
integer
Alias
- UMLS CUI [1,1]
- C0041755
- UMLS CUI [1,2]
- C0015371
- UMLS CUI [1,3]
- C0681889
Description
The Barnes Akathisia Scale Score
Data type
integer
Alias
- UMLS CUI [1]
- C3541345
Description
Abnormal Involuntary Movement Scale Score
Data type
integer
Alias
- UMLS CUI [1]
- C0450978
Description
Profile of Mood States
Data type
text
Alias
- UMLS CUI [1]
- C0451394
Description
Columbia Suicide Severity Rating Scale Score
Data type
integer
Alias
- UMLS CUI [1]
- C3888485
Description
PET Scan Post Dose 1
Alias
- UMLS CUI-1
- C0032743
Description
Date of Scan
Data type
date
Alias
- UMLS CUI [1,1]
- C0032743
- UMLS CUI [1,2]
- C0011008
Description
Examination Number
Data type
text
Alias
- UMLS CUI [1,1]
- C0032743
- UMLS CUI [1,2]
- C0582103
- UMLS CUI [1,3]
- C0237753
Description
Radiochemical purity at release
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0182638
- UMLS CUI [1,2]
- C0678739
Description
Radiochemical purity time at release
Data type
time
Alias
- UMLS CUI [1,1]
- C0182638
- UMLS CUI [1,2]
- C0678739
- UMLS CUI [1,3]
- C0040223
Description
Mass of tracer administered
Data type
float
Measurement units
- ug
Alias
- UMLS CUI [1,1]
- C1522485
- UMLS CUI [1,2]
- C0178602
Description
Volume to be administered
Data type
float
Measurement units
- mL
Alias
- UMLS CUI [1,1]
- C0009924
- UMLS CUI [1,2]
- C0449468
Description
Bolus activity injected
Data type
float
Measurement units
- MBq/mL
Alias
- UMLS CUI [1,1]
- C2986768
- UMLS CUI [1,2]
- C0205177
- UMLS CUI [1,3]
- C0032743
Description
Bolus injection start time
Data type
time
Alias
- UMLS CUI [1,1]
- C1511237
- UMLS CUI [1,2]
- C1301880
Description
Duration of bolus injection
Data type
integer
Measurement units
- mins
Alias
- UMLS CUI [1,1]
- C1511237
- UMLS CUI [1,2]
- C0449238
Description
Duration of bolus injection
Data type
integer
Measurement units
- secs
Alias
- UMLS CUI [1,1]
- C1511237
- UMLS CUI [1,2]
- C0449238
Description
Constant infusion activity concentration (at start of infusion)
Data type
float
Measurement units
- MBq/mL
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0205177
- UMLS CUI [1,3]
- C0032743
Description
Constant infusion start time
Data type
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C1301880
Description
Constant infusion stop time
Data type
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C1522314
Description
Volume of constant infusion administered
Data type
float
Measurement units
- mL
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0449468
Description
PET Scan Post Dose 2
Alias
- UMLS CUI-1
- C0032743
Description
Date of Scan
Data type
date
Alias
- UMLS CUI [1,1]
- C0032743
- UMLS CUI [1,2]
- C0011008
Description
Examination Number
Data type
text
Alias
- UMLS CUI [1,1]
- C0032743
- UMLS CUI [1,2]
- C0582103
- UMLS CUI [1,3]
- C0237753
Description
Radiochemical purity at release
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1,1]
- C0182638
- UMLS CUI [1,2]
- C0678739
Description
Radiochemical purity time at release
Data type
time
Alias
- UMLS CUI [1,1]
- C0182638
- UMLS CUI [1,2]
- C0678739
- UMLS CUI [1,3]
- C0040223
Description
Mass of tracer administered
Data type
float
Measurement units
- ug
Alias
- UMLS CUI [1,1]
- C1522485
- UMLS CUI [1,2]
- C0178602
Description
Volume to be administered
Data type
float
Measurement units
- mL
Alias
- UMLS CUI [1,1]
- C0009924
- UMLS CUI [1,2]
- C0449468
Description
Bolus activity injected
Data type
float
Measurement units
- MBq/mL
Alias
- UMLS CUI [1,1]
- C2986768
- UMLS CUI [1,2]
- C0205177
- UMLS CUI [1,3]
- C0032743
Description
Bolus injection start time
Data type
time
Alias
- UMLS CUI [1,1]
- C1511237
- UMLS CUI [1,2]
- C1301880
Description
Duration of bolus injection
Data type
integer
Measurement units
- mins
Alias
- UMLS CUI [1,1]
- C1511237
- UMLS CUI [1,2]
- C0449238
Description
Duration of bolus injection
Data type
integer
Measurement units
- secs
Alias
- UMLS CUI [1,1]
- C1511237
- UMLS CUI [1,2]
- C0449238
Description
Constant infusion activity concentration (at start of infusion)
Data type
float
Measurement units
- MBq/mL
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0205177
- UMLS CUI [1,3]
- C0032743
Description
Constant infusion start time
Data type
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C1301880
Description
Constant infusion stop time
Data type
time
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C1522314
Description
Volume of constant infusion administered
Data type
float
Measurement units
- mL
Alias
- UMLS CUI [1,1]
- C0574032
- UMLS CUI [1,2]
- C0449468
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Visit Documentation 21
- StudyEvent: ODM
C3641100 (UMLS CUI-2)
C0008976 (UMLS CUI-3)
C1762893 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,2])
C0518766 (UMLS CUI [1,3])
C0518766 (UMLS CUI [1,2])
C2348792 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,2])
C0005767 (UMLS CUI-2)
C0946444 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0042036 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0031328 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,2])
C1301880 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,3])
C0031328 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,3])
C0200354 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0946444 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,3])
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C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C0946444 (UMLS CUI [1,2])
C0008000 (UMLS CUI [1,3])
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C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0946444 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C1302413 (UMLS CUI [1,2])
C4064021 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,2])
C0430370 (UMLS CUI-2)
C0022885 (UMLS CUI-3)
C0946444 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
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C0430370 (UMLS CUI-2)
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C0430370 (UMLS CUI-2)
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C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0042014 (UMLS CUI-2)
C0946444 (UMLS CUI [1,2])
C0042014 (UMLS CUI [1,3])
C0430397 (UMLS CUI-3)
(Comment:en)
C0430397 (UMLS CUI-2)
(Comment:en)
(Comment:en)
C0430397 (UMLS CUI-2)
(Comment:en)
C1274040 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C2347373 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,2])
C0015371 (UMLS CUI [1,2])
C0681889 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0582103 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0678739 (UMLS CUI [1,2])
C0678739 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0449468 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0449468 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0582103 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C0678739 (UMLS CUI [1,2])
C0678739 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,2])
C0449468 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,2])
C0205177 (UMLS CUI [1,2])
C0032743 (UMLS CUI [1,3])
C1301880 (UMLS CUI [1,2])
C1522314 (UMLS CUI [1,2])
C0449468 (UMLS CUI [1,2])